Bengaluru: Biopharma major Biocon on Thursday announced that its subsidiary was tying up with a Mexican firm to co-develop generic recombinant human insulin for the US market.
“The tie-up with Laboratorios PiSA S.A. de C.V of Mexico is part of our strategy to address the demand for generic rh-insulin in the US, which accounts for 40 percent ($2 billion) of the $5 billion global market,” Biocon SA said in a statement here.
The partnership envisages leveraging Biocon’s plant for the drug substance with PiSA’s product facility, its proximity to the US market and Mexico’s NAFTA (North American Free Trade Agreement) membership that ensures optimal supply chain to meet the needs of the US healthcare system for an affordable rh-insulin.
As part of the cost and profit-sharing agreement, Biocon will be responsible for clinical development, regulatory approvals and marketing of the insulin in the US.
“The agreement is an extension of our decade-long partnership with PiSA, which dominates the insulin market in Mexico. Our insulin Glargine was the first to be approved in Mexico last year,” Biocon chairperson Kiran Mazumdar-Shaw said.
Biocon’s global clinical development experience with Glargine will be a useful precedent in developing rh-insulin for the US market.
“The collaboration with PiSA also enables us to manufacture the rh-insulin drug product at PiSA’s facilities in Mexico and commercialise it under our brand (Biocon) in the US where 1.4 million people are diagnosed with diabetes every year,” Shaw said on the occasion.
According to PiSA chairman Carlos Alvarez Bermejillo, the partnership with Biocon is a milestone in his company’s strategy to enter the US sterile injectable market.
“As we have been marketing insulin products based on Biocon’s API for many years, the partnership to develop generic rh-insulin products represents a natural progression of a firm relationship between the two firms,” Bermejillo added.